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INTERNATIONAL NARCOTICS CONTROL BOARD

Guide on

Estimating Requirements

for Substances

under International Control

Developed by the International Narcotics Control Board

and the World Health Organization for use

by Competent National Authorities

UNITED NATIONS

INTERNATIONAL NARCOTICS WORLD HEALTH ORgANIzATION

CONTROL BOARD

Guide on Estimating Requirements for Substances under International Control Developed by the International Narcotics Control Board and the World Health Organization for use by Competent National Authorities United nations new York, 2012

UNITED NATIONS PUBLICATION

The designations employed and the presentation of material in this publication do not imply the expression of any opinion whatsoever on the part of the Secretariat of the United Nations concerning the legal status of any country, territory, city or area, or of its authorities, or concerning the delimitation of its frontiers or boundaries.

Foreword The International Narcotics Control Board (INCB) is launching the Guide on Estimating Requirements for Substances under International Control on the occasion of the centennial of the first international drug control treaty, the International Opium Convention signed at The Hague on 23 January 1912, which was the cornerstone of international drug control. Drug abuse was a scourge that was widespread, affecting most regions of the world, when the 1912 Convention was adopted. Subsequently, an international drug control system was established. The current system is based on the three international drug control conventions: the Single Convention on Narcotic Drugs of 1961 as amended by the 1972 Protocol; the Convention on Psychotropic Substances of 1971; and the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988. The international drug control system endeavours to prevent the abuse of drugs, as well as the harm caused by such abuse, while ensuring adequate availability of drugs for the treatment of pain and mental illness.

The problem of inappropriate levels of consumption of internationally controlled substances (too high in some countries and too low in others) has been a matter of concern to INCB for many years. In January 2011, the Report of the International Narcotics Control Board on the Availability of Internationally Controlled Drugs: Ensuring Adequate Access for Medical and Scientific Purposes1 was published. The Report contained a detailed analysis of the global situation with regard to the availability of internationally controlled drugs for medical and scientific purposes and showed the disparity in that availability among the various regions of the world.

Australia, Canada, New Zealand and the United States of America, in addition to several European countries, account for 90 per cent of global consumption of analgesics. In some of these countries, there is overconsumption of certain controlled substances, which may cause additional health problems or further compound existing conditions.

In contrast, 80 per cent of the world’s population has limited or no access to these medicines, meaning that many individuals suffer unnecessarily. Many medical conditions cannot be adequately treated without access to the narcotic drugs used, for example in the treatment of pain, or to the psychotropic substances used in the treatment of mental and neurological conditions.

Impediments to the adequate availability of internationally controlled substances vary between countries, and it is the responsibility of national authorities to identify these impediments and take appropriate measures to remove them. However, INCB is of the opinion that the first step that needs to be taken is the identification of a country’s actual requirements for internationally controlled substances in order to overcome underconsumption and, at the same time, prevent overconsumption.

United Nations publication, Sales No. E.11.XI.7 iii The importance of identifying actual national requirements was reiterated by the Commission on Narcotic Drugs in its resolution 54/6 on promoting adequate availability of internationally controlled narcotic drugs and psychotropic substances for medical and scientific purposes while preventing their diversion and abuse. In the resolution, the Commission encouraged INCB to continue its efforts, in cooperation with the World Health Organization (WHO), to develop guidelines to assist Member States in estimating their medical and scientific requirements for internationally controlled narcotic drugs and psychotropic substances.

Countries that are in a position to adequately estimate and assess their requirements for narcotic drugs and psychotropic substances are usually the ones that are able to take the steps required to improve availability. The process of establishing the mechanism and developing the expertise to make adequate estimates and assessments of legitimate requirements leads to improved supply of internationally controlled substances. Obtaining accurate information about the legitimate requirements for such substances is a prerequisite to ensuring their availability.

INCB is aware that the success of such efforts depends, to a large extent, on a well-functioning drug control system. Without an effective drug control system, countries will find it much more difficult to assess their present consumption levels, identify the additional quantities required for existing treatment facilities and define the improvements required in the health-care infrastructure and the drug distribution system so that patients can be given the medications they need.

Unfortunately, many countries still find it difficult to identify their actual requirements of narcotic drugs and psychotropic substances and are therefore unable to provide adequate estimates and assessments or, in some cases, to provide any estimates at all. In order to support these countries, a working group comprising representatives of INCB, WHO and the WHO Collaborating Centre for Pain Policy and Palliative Care, together with several independent experts, developed the present Guide. The national regulatory agencies of countries at different stages of development were asked to provide their comments, with a view to ensuring that the Guide would be as widely applicable as possible.

The Guide is meant to assist Governments of countries with low levels of consumption of controlled substances in calculating their requirements so that they can then submit to INCB estimates and assessments that accurately reflect those requirements. It could also be useful for Governments of countries in which the consumption levels for some substances are disproportionately high. I hope that the Guide will be widely used by competent national authorities and will ultimately help them to arrive at estimates and assessments that reflect their actual requirements for internationally controlled substances.

Hamid GhodsePresidentInternational Narcotics Control Board

iv Preface The INCB-WHO Guide on Estimating Requirements for Substances under International Control is intended to assist competent national authorities in identifying methods for calculating the quantities of controlled substances required for medical and scientific purposes. At the same time, it will help those authorities to prepare the estimates and assessments of annual requirements for controlled substances that countries are required to furnish to the International Narcotics Control Board (INCB). It describes the system of estimates and assessments and the various methods commonly used to quantify the requirements of controlled substances for medical and scientific purposes.

It also provides an overview of the major issues that need to be considered in order to apply these methods accurately.

Several methods have been developed for calculating the requirements of controlled substances for medical purposes (see section II.B and annex I). No single method should be systematically recommended for all countries because the choice of method depends on the specific conditions in each country. This Guide has been

prepared to help competent national authorities:

(a) To identify the most appropriate method (or methods);

(b) To improve the accuracy of the method (or methods) in use;

(c) To calculate estimates and assessments of controlled substances to be furnished to INCB;

(d) To train staff working in drug regulatory administrations.

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1. The international drug control regime is based on three international conventions: the Single Convention on Narcotic Drugs of 1961 as amended by the 1972 Protocol, the Convention on Psychotropic Substances of 1971 and the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988. The 1961 Convention as amended and the 1971 Convention established control measures for narcotic drugs and psychotropic substances, whereas the 1988 Convention established control measures for precursor chemicals used in the illicit manufacture of narcotic drugs and psychotropic substances. By becoming parties to these conventions, States accept the obligation to implement in their national legislation the provisions of the conventions. For the purpose of this Guide, the substances controlled under the three conventions will be referred to as controlled substances.

2. The international drug control conventions were elaborated in recognition of the fact that certain substances, while being of great benefit to mankind, also had the potential to cause harm, such as dependence syndrome. Therefore, the conventions established a control regime that would ensure the availability of controlled substances for medical and scientific purposes while preventing their illicit production, trafficking and abuse. An essential component of this regime is a system under which Governments are requested to estimate the quantities of controlled substances required for legitimate purposes and to limit the use of and trade in such substances to within those estimates. If applied correctly, this system should not hinder but rather promote access to appropriate amounts of controlled substances and should prevent their excessive use.

3. The International Narcotics Control Board (INCB) is the body responsible for monitoring the compliance of Governments with the international drug control treaties and for providing support to Governments in this respect. The ability of INCB to monitor the functioning of the international drug control mechanisms established by the conventions relies, in part, on Governments providing it with estimated quantities of controlled substances required for legitimate purposes in their countries (these quantities are known as estimates1 when referring to narcotic drugs or precursor chemicals and as assessments when referring to psychotropic substances).

4. The World Health Organization (WHO) carries out a number of activities to ensure adequate treatment of patients, including the elaboration of treatment guidelines and the Model List of Essential Medicines.2 WHO also provides guidance to Governments on policies and legislation on the availability, accessibility, affordability and control of medicines made from controlled substances.

5. The accurate estimation of requirements for controlled substances is an essential step in ensuring their adequate supply for medical and scientific purposes. On the one hand, underestimation of requirements can contribute to many problems in the use of controlled substances in the health-care system, notably shortages, inappropriate prescribing, distortion of demand and lack of cost-effectiveness; on the other hand, overestimation can lead to surpluses, wastage and increased risk of diversion of controlled substances.

6. In principle, the process of estimating requirements for controlled substances should be based on effective methods and systematic procedures for collecting information about the use of and See section III for information on estimates and assessments.

Available from the WHO Essential Medicines Library, at http://apps.who.int/emlib/.

2 Guide on Estimating Requirements for Substances under International Control need for controlled substances. However, a number of factors make it difficult for the competent authorities of many countries to develop and use such methods and procedures. The most common difficulties encountered include a lack of technical knowledge, a general lack of resources, a poorly developed health-care infrastructure and the absence of an institutional framework that prioritizes access to medicines for all segments of the population. As a result, many Governments either fail to furnish any estimates or assessments at all to INCB, or they submit inaccurate estimates and assessments that exceed or fall short of their actual requirements.

A. System of estimates and assessments Legal framework of the system

7. The present system of estimates of narcotic drugs was established by the 1961 Convention (articles 12 and 19).3 Although the 1971 Convention did not establish a similar system for psychotropic substances, the Economic and Social Council, in its resolutions 1981/7 and 1991/44, invited Governments to provide to INCB assessments of their medical and scientific requirements for substances in Schedules II, III and IV of the 1971 Convention. Similarly, in its resolution 49/3, the Commission on Narcotic Drugs requested Member States to provide to INCB annual estimates of their legitimate requirements for 3,4-methylenedioxyphenyl-2-propanone (3,4-MDP-2-P), pseudoephedrine, ephedrine and 1-phenyl-2-propanone (P-2-P) (precursor chemicals frequently used in the illicit manufacture of amphetamine-type stimulants) and, to the extent possible, estimated requirements for imports of preparations containing those substances that could be easily used or recovered by readily applicable means.

Functions of estimates and assessments

8. Estimates and assessments should be based on legitimate medical and scientific requirements.4

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